A long-awaited FDA draft guidance released last week clarifies the agency’s position on the design, planning and conduct of decentralized trials (DCT) but is notably silent on the question of responsibility for oversight of home health visits, a key issue for sites and sponsors.

Though the agency initially provided direction on managing and implementing DCT elements in its March 2020 guidance on conducting trials during the COVID-19 pandemic (CenterWatch Weekly, March 22, 2020), industry has repeatedly called for clearer, specific guidance on the subject of DCTs.

The 19-page draft guidance offers considerations for several critical DCT components, including:

• DCT designs;
• Remote trial activities/visits;
• Use of digital health technologies;
• Sponsor and investigator roles and responsibilities;
• Informed consent and institutional review board (IRB) oversight;
• Investigational products, including direct-to-patient shipments of these products;
• Safety monitoring plans for DCTs; and
• Software involved in the conduct of DCTs.

The guidance advises that completely decentralized trials may be appropriate for investigational products that are easy to administer or use, have established safety profiles and do not require complex medical assessments of participants.

But even trials considered by the agency to be fully remote should have a physical location to facilitate FDA inspection of participant records and staff interviews, the agency explains.

For more complex investigational products, such as treatments that must be administered at a site or have intricate medical assessments as part of their trials, hybrid DCTs are a more realistic option, the guidance says. In these situations, hybrid components could come in the form of follow-up assessments that can be done remotely via local healthcare providers, patient-reported outcome measures, or telehealth or at-home visits.

While the guidance clarifies that a trial’s principal investigator (PI) is still in charge of overseeing study procedures whether they’re done at a site or remotely, it is notably devoid of direction on responsibilities for overseeing home health visits.

From the PI perspective, the concern with home health visits — and sponsors’ increasing use of home health visit vendors — is that they are unable to vouch for the training and delegation of responsibilities of these vendors. This has been an area of great concern for all trial stakeholders, and PIs in particular, for some time and likely will figure prominently in public comments on the draft guidance (CenterWatch Weekly, May 9, 2022).

Another likely pain point for PIs and sites is the addition of a trial “task log” when in-person visits are assigned to local healthcare providers, which the guidance advises “when permitted by the
trial protocol.” This task log should include the names and affiliations of local healthcare providers, descriptions of their assigned roles and tasks, the dates they were added to the log and the locations where they carry out the relevant trial activities.

This additional recordkeeping responsibility is likely to draw comment as well. Some stakeholders may argue for simply adding these providers to the existing delegation of authority log rather than having to maintain a separate document.

Comments on the draft guidance are due by Aug. 1.

Read the draft guidance here: https://bit.ly/415O1n1.